What changed in this filing

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Item 1A. Risk Factors

2024-03-14 compared with 2023-03-16 · 200 added, 319 removed, 488 unchanged (52% of the section changed)

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as of December 31, 2023 and 2022, respectively.

We were able to achieve net income during the calendar year ending December 31, 2021

due to the high demand for our Logix Smart COVID-19 and other COVID-19 tests during the COVID pandemic.

During the calendar year ending

December 31, 2022 we experienced a decline in demand for our Logix Smart COVID-19 and other COVID-19 tests and operated at a net loss

during the period.

We do not have any way of predicting when or if we will achieve profitability again.

Potential investors should be

aware of the difficulties normally encountered by a new enterprise, many of which are beyond our control, including substantial risks

and expenses in the course of developing new diagnostic tests, establishing or entering new markets, organizing operations and marketing

The likelihood of our success must be considered in light of these risks, expenses, complications and delays, and the competitive

environment in which we operate.

There is, therefore, nothing at this time upon which to base an assumption that our business plan will

prove successful, and we may not be able to generate significant revenue, raise additional capital or operate profitably.

We will continue

to encounter risks and difficulties frequently experienced by early commercial stage companies, including scaling up our infrastructure

and headcount, and may encounter unforeseen expenses, difficulties or delays in connection with our growth.

In addition, as a result

of the start-up nature of our business, we expect to continue to sustain substantial operating expenses and may not be able to continue

generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could result

in the loss of any investment.

future success is dependent on demand for COVID-19 and other infectious disease diagnostics and upon our ability to develop and market

other commercially accepted diagnostic tests and our “at-home” and POCT platforms.

future success will depend, in part, on the continued market for COVID-19 tests, our ability to develop and sell sufficient quantities

of other diagnostics tests, and our ability to successfully obtain regulatory approval for and profitably market our Co-Dx PCR Home at-home

and POCT platform.

Attracting new customers and distribution networks requires substantial time and expense.

Any failure to obtain regulatory

approval for our product candidates and to increase sales of our diagnostic tests in sufficient quantities to achieve profitability in

a timely manner would adversely affect our operating results.

Many factors could affect the market acceptance and commercial success

of any of our diagnostic tests and devices, including:

Our ability to develop

additional infectious disease diagnostic tests for which there is a commercial market;

Our ability to obtain regulatory

clearance to commercialize our product candidates;

our ability to convince

our potential customers of the advantages and economic value of our tests over competing technologies and diagnostic tests;

the breadth of our test

menu relative to competitors;

changes to policies, procedures

or currently accepted best practices in clinical diagnostic testing;

the extent and success

of our marketing and sales efforts;

our ability to manufacture

in quantity our commercial diagnostic tests and meet demand in a timely fashion.

may not realize anticipated revenue from our Logix Smart COVID-19 and other COVID-19 tests.

our business is substantially dependent on sales of our Logix Smart COVID-19 and other COVID-19 tests.

Other companies are working to

produce or have produced rapid tests for COVID-19 which may lead to the diversion of customers, including governmental and quasi-governmental

entities, away from us and toward other companies.

Moreover, the dangers posed by COVID-19 may subside over time.

A number of preventative

vaccines have been approved for use in human populations by regulatory agencies in the U.S.

and around the world.

The uptake of these

vaccines will likely limit the spread of COVID-19 and potentially reduce the market size for COVID-19 testing.

expect that, if and when the current COVID-19 pandemic subsides, there could be significantly reduced demand for testing, and thus, for

our Logix Smart COVID-19 and other COVID-19 tests.

We have seen a reduction in the prevalence of COVID-19 since the height of the pandemic,

and in 2022 experienced a significant decrease in revenue from our COVID-19 testing products.

Revenues relating to our COVID-19 testing

products could decline in the future if the prevalence of COVID-19 remains low and as attention from governments and individuals to COVID-19

if the COVID-19 pandemic becomes a seasonal virus or experiences fluctuations in prevalence, we could experience fluctuations in

our revenues associated with our COVID-19 tests.

While there is still demand for COVID-19 testing products, there is no guarantee that

current or anticipated demand will continue, or if demand does continue, that we will be able to produce our COVID-19 tests in sufficient

quantities to meet demand.

A significant decline in demand for our COVID-19 testing products without a corresponding increase in our

other businesses could have a material, adverse effect on our results of operations, cash flow and financial position.

During the calendar years ending December 31, 2023 and 2022 we experienced a decline

in demand for our Logix Smart COVID-19 and other COVID-19 tests and operated at a net loss during the periods.

We do not have any way

of predicting when or if we will achieve profitability again.

Potential investors should be aware of the difficulties normally encountered

by a new enterprise, many of which are beyond our control, including substantial risks and expenses in the course of developing new diagnostic

tests, establishing or entering new markets, organizing operations and marketing procedures.

The likelihood of our success must be considered

in light of these risks, expenses, complications and delays, and the competitive environment in which we operate.

There is, therefore,

nothing at this time upon which to base an assumption that our business plan will prove successful, and we may not be able to generate

significant revenue, raise additional capital or operate profitably.

We will continue to encounter risks and difficulties frequently

experienced by early commercial stage companies, including scaling up our infrastructure and headcount, and may encounter unforeseen

expenses, difficulties or delays in connection with our growth.

In addition, as a result of the start-up nature of our business, we expect

to continue to sustain substantial operating expenses and may not be able to continue generating sufficient revenues to cover expenditures.

Any investment in our company is therefore highly speculative and could result in the loss of any investment.

future success is dependent on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including

the PCR Pro instrument and related diagnostic tests, demand for infectious disease diagnostics and upon our ability to develop and market

other commercially accepted diagnostic tests for our PCR platform.

future success will depend, in part, on our development of our Co-Dx PCR platform and securing regulatory approval for the platform including

the PCR Pro instrument and related diagnostic tests, our ability to develop and sell sufficient quantities of other diagnostics tests,

and our ability to successfully and profitably market our Co-Dx PCR platform.

Attracting new customers and distribution networks requires

substantial time and expense.

Any failure to obtain regulatory approval for our product candidates and to increase sales of our diagnostic

tests in sufficient quantities to achieve profitability in a timely manner would adversely affect our operating results.

could affect the market acceptance and commercial success of any of our diagnostic tests and devices, including:

ability to develop additional infectious disease diagnostic tests for which there is a commercial market;

ability to obtain regulatory clearance to commercialize our product candidates;

ability to convince our potential customers of the advantages and economic value of our tests over competing technologies and diagnostic

breadth of our test menu relative to competitors;

to policies, procedures or currently accepted best practices in clinical diagnostic testing;

extent and success of our marketing and sales efforts;

ability to manufacture in quantity our commercial diagnostic tests and meet demand in a timely fashion.

diagnostic market is highly competitive, and we may not be able to compete effectively against the larger, well-established companies

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companies enjoy significant competitive advantages over us, including:

broad product

offerings, which address the needs of health care providers in a wide range of applications;

products that are supported

by long-term clinical data;

greater experience in,

and resources for, launching, marketing, distributing and selling products, including strong sales forces and established distribution

extensive intellectual

property portfolios and greater resources for patent protection;

greater financial and other

resources for product research and development;

greater experience in obtaining

and maintaining FDA and other regulatory clearances and approvals for products and product enhancements;

established manufacturing

operations and contract manufacturing relationships;

significantly greater name

recognition and widely recognized trademarks;

established relationships

with healthcare providers and payers.

product offerings, which address the needs of health care providers in a wide range of applications;

that are supported by long-term clinical data;

experience in, and resources for, launching, marketing, distributing and selling products, including strong sales forces and established

distribution networks;

intellectual property portfolios and greater resources for patent protection;

financial and other resources for product research and development;

experience in obtaining and maintaining FDA and other regulatory clearances and approvals for products and product enhancements;

manufacturing operations and contract manufacturing relationships;

significantly

greater name recognition and widely recognized trademarks;

relationships with healthcare providers and payers.

products and any product candidates that we may introduce into the market may not enable us to overcome the competitive advantages of

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effect on our reputation, business, results of operations and financial condition.

security risks and the failure to maintain the integrity of company, employee or guest data could expose us to data loss, litigation

and liability, and our reputation could be significantly harmed.

and third-party service providers collect and retain large volumes of data, including personally identifiable information regarding clinical trial participants

and others, for business purposes, including for regulatory, research and development and commercialization purposes, and our collaborators’

various information technology systems enter, process, summarize and report such data.

We also maintain personally identifiable information

about our employees.

The integrity and protection of our company, employee and clinical data is critical to our business.

We are subject

to significant data security and privacy laws and regulations.

These regulations impose significant requirements on how we maintain,

use, and protect such information.

Maintaining compliance with these evolving regulations and requirements could be difficult and may

increase our expenses.

In addition, a penetrated or compromised data system or the intentional, inadvertent or negligent release or disclosure

of data could result in theft, loss or fraudulent or unlawful use of company, employee or clinical data which could harm our reputation,

disrupt our operations, or result in remedial and other costs, fines or lawsuits.

Cybersecurity

risks and the failure to maintain the integrity of company, employee or customer data could expose us to data loss, litigation and liability,

and our reputation could be significantly harmed.

and third-party service providers collect and retain large volumes of data, including personally identifiable information regarding clinical

trial participants and others, for business purposes, including for regulatory, research and development and commercialization purposes,

and our collaborators’ various information technology systems enter, process, summarize and report such data.

We also maintain

personally identifiable information about our employees.

The integrity and protection of our company, employee and clinical data is critical

to our business.

We are subject to significant data security and privacy laws and regulations.

These regulations impose significant requirements

on how we maintain, use, and protect such information.

Maintaining compliance with these evolving regulations and requirements could

be difficult and may increase our expenses.

In addition, a penetrated or compromised data system or the intentional, inadvertent or negligent

release or disclosure of data could result in theft, loss or fraudulent or unlawful use of company, employee or clinical data which could

harm our reputation, disrupt our operations, or result in remedial and other costs, fines or lawsuits.

Related to Regulatory Approval of Our Products and Other Government Regulations

received Emergency Use Authorization or EUA and intend to seek additional and/or amended EUAs for our COVID-19 test.

The FDA may not

timely grant any additional or amended EUAs, if at all.

For our existing EUA and any new EUA, the FDA may revoke any EUA where it is

determined that the underlying health emergency no longer exists or warrants such authorization, which would adversely impact our ability

to market our COVID-19 test in the United States.

received Emergency Use Authorization or EUA for our COVID-19 test in US.

We applied for Emergency Use Authorization for our PCR platform

which included the PCR Pro instrument and the COVID 19 diagnostic test cup and mobile app.

The FDA may not timely grant the EUA we filed

for the PCR platform or may require that we submit a 510K application rather than EUA.

For our existing EUA and any new EUA, the FDA

may revoke any EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization, which

would adversely impact our ability to market our COVID-19 test in the United States.

FDA has the authority to grant an EUA to allow unapproved medical products to be used in an emergency to diagnose, treat or prevent serious

or life-threatening diseases or conditions when there are no adequate, approved and available alternatives.

On January 31, 2020, the

Secretary of the U.S.

Department of Health and Human Services, or U.S.

HHS, issued a declaration of a public health emergency related

On February 4, 2020, U.S.

HHS determined that COVID-19 represents a public health emergency that has a significant potential

to affect national security or the health and security of U.S.

citizens living abroad and, subsequently, declared on March 24, 2020,

that circumstances exist to justify the authorization of emergency use of medical devices, including alternative products used as medical

devices, during the COVID-19 pandemic, subject to the terms of any authorization as issued by the FDA.

On February 29, 2020, the FDA

issued an immediately in effect guidance with policy specific to development of in vitro diagnostic tests during the COVID-19

public health emergency.

This guidance was updated on March 16, 2020, May 4, 2020 and May 11, 2020.

It is uncertain whether the widespread

availability of approved and effective vaccinations could expedite or influence any such decision making with respect to the underlying

health emergency.

April 3, 2020, we received an EUA from the FDA for our Logix Smart Coronavirus Disease 2019 (COVID-19) kit for use on individuals who

are suspected of COVID-19 by their healthcare provider.

We cannot predict how long the EUA for

our COVID-19 test will remain in place.

can be no assurances that the FDA will authorize any request for additional and/or amended EUAs and if we do not receive the authorization,

our business, financial condition, results of operations and future growth prospects could be materially and adversely affected.

FDA may revoke an EUA where it is determined that the underlying health emergency no longer exists or warrants such authorization.

FDA may take such a position at any time and without notice and, therefore, we cannot predict how long our EUAs will remain in place.

The FDA may also revoke an EUA when the circumstances justifying its issuance no longer exist, such as when an alternative is authorized

for marketing through the standard procedures, including through a 510(k) clearance.

policies regarding diagnostic tests, therapies and other products used to diagnose, treat or mitigate COVID-19 remain in flux as the

FDA responds to new and evolving public health information and clinical evidence.

Changes to FDA regulations or requirements could require

changes to our authorized test, necessitate additional measures, or make it impractical or impossible for us to market our test.

revocation of an EUA, if granted, could necessitate that we pursue the lengthy and expensive 510(k) clearance process, if available,

or another similarly burdensome marketing authorization process, such as a de novo classification.

Indeed, FDA has recommended that manufacturers

of tests subject to an EUA pursue pre-market submissions such as a 510(k), de novo classification, or pre-market approval, or PMA, as

applicable, during the declared public health emergency so that their devices can remain on the market after the emergency terminates.

either of our existing EUAs is revoked prior to us having received regulatory approval to commercialize our COVID-19 test through a traditional

pathway, we may not be able to obtain required clearances or approvals in a timely manner, or at all, and one or more of our competitors

may obtain the necessary clearances or approvals for their products before we do.

In addition, we would be required to cease our commercialization

efforts, which would substantially and negatively impact our business.

As a result, any such revocation could adversely impact our business,

financial condition and results of operations.

During the COVID 19 pandemic

the FDA determined that circumstances exist to justify the authorization of emergency use of medical devices, including alternative products

used as medical devices, during the COVID-19 pandemic.

On April 3, 2020, we received an EUA from the FDA for our Logix Smart Coronavirus

Disease 2019 (COVID-19) kit for use on individuals who are suspected of COVID-19 by their healthcare provider.

cannot predict how long the EUA for our COVID-19 test will remain in place.

The FDA may revoke an EUA where it is determined that

the underlying health emergency no longer exists or warrants such authorization.

The FDA may take such a position at any time and without

notice and, therefore, we cannot predict how long our EUAs will remain in place.

The FDA may also revoke an EUA when the circumstances

justifying its issuance no longer exist, such as when an alternative is authorized for marketing through the standard procedures, including

through a 510(k) clearance.

applied for Emergency Use Authorization for our PCR platform which included the PCR Pro instrument and the COVID 19 diagnostic test cup

and mobile app.

The FDA may not timely grant the EUA we filed for the PCR platform or may require that we submit a 510K application rather

than EUA which could extend the time for authorization to begin commercializing the PCR platform.

There can be no assurances that the

FDA will authorize any request for additional and/or amended EUAs and if we do not receive the authorization, our business, financial

condition, results of operations and future growth prospects could be materially and adversely affected.

either of our existing EUAs is revoked or our existing EUA applications are denied prior to us having received regulatory approval to

commercialize our COVID-19 test through a traditional pathway, we may not be able to obtain required clearances or approvals in a timely

manner, or at all, and one or more of our competitors may obtain the necessary clearances or approvals for their products before we do.

In addition, we would be required to cease our commercialization efforts, which would substantially and negatively impact our business.

As a result, any such revocation could adversely impact our business, financial condition and results of operations.

long-term success depends substantially on our ability to obtain regulatory clearance or approval and thereafter commercialize our product

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state and foreign healthcare laws and regulations that may affect our ability to operate include:

the federal Anti-Kickback

Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving or providing remuneration,

directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral of an individual for, or the

purchase, order or recommendation of, any good or service, for which payment may be made under federal healthcare programs, such

as Medicare and Medicaid;

federal civil and criminal

false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal and civil penalties,

including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting, or causing to be presented,

to the federal government, including the Medicare and Medicaid programs, claims for payment that are false or fraudulent or making

a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

the federal Health Insurance

Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing a scheme to defraud

any healthcare benefit program or making false statements relating to healthcare matters;

HIPAA, as amended by the

Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing regulations,

which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their business

associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a covered

entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

the Physician Payments

Sunshine Act, which requires (i) manufacturers of drugs, devices, biologics and medical supplies for which payment is available under

Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually to CMS information

related to certain “payments or other transfers of value” made to physicians, which is defined to include doctors, dentists,

optometrists, podiatrists and chiropractors, and teaching hospitals, (ii) applicable manufacturers and applicable group purchasing

organizations to report annually to CMS ownership and investment interests held in such entities by physicians and their immediate

family members, with data collection beginning on August 1, 2013, (iii) manufacturers to submit reports to CMS by the 90th day of

each calendar year, and (iv) disclosure of such information by CMS on a publicly available website;

analogous state and foreign

laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing arrangements and claims

involving healthcare items or services reimbursed by non-governmental third-party payers, including private insurers;

state and foreign

laws that require medical device companies to comply with the medical device industry’s voluntary compliance guidelines and

the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to healthcare

state and foreign laws that require medical device manufacturers to report information related to payments and other transfers

of value to physicians and other healthcare providers or marketing expenditures;

and state and foreign laws governing the privacy

and security of health information in certain circumstances, many of which differ from each other in significant ways and often are

not preempted by HIPAA, thus complicating compliance efforts.

federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, offering, receiving

or providing remuneration, directly or indirectly, in cash or in kind, to induce or reward, or in return for, either the referral

of an individual for, or the purchase, order or recommendation of, any good or service, for which payment may be made under federal

healthcare programs, such as Medicare and Medicaid;

civil and criminal false claims laws and civil monetary penalty laws, including the federal False Claims Act, which impose criminal

and civil penalties, including civil whistleblower or qui tam actions, against individuals or entities for knowingly presenting,

or causing to be presented, to the federal government, including the Medicare and Medicaid programs, claims for payment that are

false or fraudulent or making a false statement to avoid, decrease or conceal an obligation to pay money to the federal government;

federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, which imposes criminal and civil liability for executing

a scheme to defraud any healthcare benefit program or making false statements relating to healthcare matters;

as amended by the Health Information Technology for Economic and Clinical Health Act of 2009, or HITECH, and their respective implementing

regulations, which impose obligations on covered healthcare providers, health plans, and healthcare clearinghouses, as well as their

business associates that create, receive, maintain or transmit individually identifiable health information for or on behalf of a

covered entity, with respect to safeguarding the privacy, security and transmission of individually identifiable health information;

Physician Payments Sunshine Act, which requires (i) manufacturers of drugs, devices, biologics and medical supplies for which payment

is available under Medicare, Medicaid or the Children’s Health Insurance Program, with specific exceptions, to report annually

to CMS information related to certain “payments or other transfers of value” made to physicians, which is defined to

include doctors, dentists, optometrists, podiatrists and chiropractors, and teaching hospitals, (ii) applicable manufacturers and

applicable group purchasing organizations to report annually to CMS ownership and investment interests held in such entities by physicians

and their immediate family members, with data collection beginning on August 1, 2013, (iii) manufacturers to submit reports to CMS

by the 90 th day of each calendar year, and (iv) disclosure of such information by CMS on a publicly available website;

state and foreign laws and regulations, such as state anti-kickback and false claims laws, which may apply to sales or marketing

arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payers, including private

state and foreign laws that require medical device companies to comply with the medical device industry’s voluntary

compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that

may be made to healthcare providers;

state and foreign laws that require medical device manufacturers to report information related

to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures;

and state and foreign

laws governing the privacy and security of health information in certain circumstances, many of which differ from each other in significant

ways and often are not preempted by HIPAA, thus complicating compliance efforts.

to ensure that our business arrangements with third parties will comply with applicable healthcare laws and regulations may involve substantial

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sanctions, including exclusions from participation in government healthcare programs, which could also materially affect our business.

are subject to stringent and changing data protection laws, privacy policies and data protection obligations, which continue to evolve and change over time.

The actual or perceived

failure by us or our third-party service providers or vendors to comply with such obligations could harm our reputation, subject us to

significant fines and liability, or otherwise adversely affect our business.

are subject to stringent and changing data protection laws, privacy policies and data protection obligations, which continue to evolve

and change over time.

The actual or perceived failure by us or our third-party service providers or vendors to comply with such obligations

could harm our reputation, subject us to significant fines and liability, or otherwise adversely affect our business.

are subject to numerous data protection laws that govern the processing of individually identifiable information and health information

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enacted to strengthen elements of the CCPA and became effective on January 1, 2023.

The CPRA imposes additional data protection

obligations on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for

higher risk data, and opt outs for certain uses of sensitive data and expands the application of the CCPA to all human resources personal

information of California-based employees.

In addition, the CPRA created a new California data protection agency authorized to issue

substantive regulations and is expected to result in increased privacy and information security enforcement.

A number of other states

have considered similar privacy proposals, and states have recently enacted their own privacy laws.

For example, the Virginia Consumer

Data Protection Act became effective on January 1, 2023, and Colorado and Utah enacted similar laws that will also become effective in

2023, increasing the complexity of compliance and the risk of failures to comply.

These privacy laws may impact our business activities

and exemplify the vulnerability of our business to the evolving regulatory environment related to personal data.

The CPRA imposes additional data protection obligations

on covered businesses, including additional consumer rights processes, limitations on data uses, new audit requirements for higher risk

data, and opt outs for certain uses of sensitive data and expands the application of the CCPA to all human resources personal information

of California-based employees.

In addition, the CPRA created a new California data protection agency authorized to issue substantive

regulations and is expected to result in increased privacy and information security enforcement.

A number of other states have considered

similar privacy proposals, and states have recently enacted their own privacy laws.

For example, the Virginia Consumer Data Protection

Act became effective on January 1, 2023, and Colorado and Utah enacted similar laws that became effective in 2023, increasing

the complexity of compliance and the risk of failures to comply.

These privacy laws may impact our business activities and exemplify

the vulnerability of our business to the evolving regulatory environment related to personal data.

addition to our operations in the United States, which may be subject to health care and other laws relating to the privacy and security

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and retain new clients or partners.

legislation in the U.S.

Congress, including changes in U.S.

tax law, and the recently enacted Inflation Reduction Act of 2022 may adversely

impact us and the value of common shares, pre-funded warrants, and Warrants.

tax laws (which changes may have retroactive application) could adversely affect us or holders of common shares.

In recent years,

many changes to U.S.

federal income tax laws have been proposed and made, and additional changes to U.S.

federal income tax laws are

likely to continue to occur in the future.

Congress is currently considering numerous items of legislation which may be enacted prospectively or with retroactive effect, which

legislation could adversely impact our financial performance and the value of common shares.

If enacted, most of the proposals would

be effective for the current or later years.

The proposed legislation remains subject to change, and its impact on us and the holders

of common shares is uncertain.

addition, the Inflation Reduction Act of 2022 was recently signed into law and includes provisions that will impact the U.S.

income taxation of corporations.

Among other items, this legislation includes provisions that will impose a minimum tax on the book income

of certain large corporations and an excise tax on certain corporate stock repurchases that would be imposed on the corporation repurchasing

It is unclear how this legislation will be implemented by the U.S.

Department of the Treasury, and we cannot predict how

this legislation or any future changes in tax laws might affect us or holders of common shares, pre-funded warrants or Warrants.

Related to Our Intellectual Property

100 unchanged sentences

For example, we are currently parties to two securities class action claims and three derivative actions.

On March 20, 2020,

we received a voluntary request for documents from the SEC relating to disclosures regarding our COVID-19 test and other matters.

that time we and certain of our current and former officers have been cooperating with the SEC and providing documents and information.

The Company has entered into negotiations with the SEC in an attempt to reach a consensual resolution of the matters raised in the SEC’s

investigation.

Any such resolution may include the imposition of civil penalties, injunctive and other relief against the Company, senior

management and related individuals.

We cannot predict the outcome of these negotiations or of the SEC’s investigation at this time,

however, to the best of our knowledge, we do not believe that the matter is reasonably likely to result in financial penalties having

a material adverse effect on the Company.

Litigation and other legal proceedings are inherently unpredictable and can result in excessive

or unanticipated verdicts and/or injunctive relief that affect how we operate our business.

We could incur judgments or enter into settlements

of claims for monetary damages or for agreements to change the way we operate our business, or both.

There may be an increase in the

scope of these matters or there may be additional lawsuits, claims, proceedings or investigations in the future, which could harm our

business, financial condition and results of operations.

Adverse publicity about regulatory or legal action against us could damage our

reputation and brand image, undermine our customers’ confidence and reduce long-term demand for any of our products or other offerings,

even if the regulatory or legal action is unfounded or not material to our operations.

Litigation and other

legal proceedings are inherently unpredictable and can result in excessive or unanticipated verdicts and/or injunctive relief that affect

how we operate our business.

We could incur judgments or enter into settlements of claims for monetary damages or for agreements to change

the way we operate our business, or both.

There may be an increase in the scope of these matters or there may be additional lawsuits,

claims, proceedings or investigations in the future, which could harm our business, financial condition and results of operations.

publicity about regulatory or legal action against us could damage our reputation and brand image, undermine our customers’ confidence

and reduce long-term demand for any of our products or other offerings, even if the regulatory or legal action is unfounded or not material

to our operations.

For additional information, see “Item 3.

4 unchanged sentences

Factors” section and elsewhere in this report, are:

sales of our common stock

by our shareholders, executives, and directors;

ability to obtain regulatory approval to commercialize our “at-home” and POCT product candidates on a timely basis or at

our ability to enter new

actual or unanticipated

fluctuations in our annual and quarterly financial results;

our ability to obtain financings

to continue and expand our commercial activities, expand our manufacturing operations, conduct research and development activities

including, but not limited to, human clinical trials, and other business activities;

our ability to secure resources

and the necessary personnel to continue and expand our commercial activities, develop additional diagnostic tests, conduct clinical

trials and gain approval for our diagnostic tests on our desired schedule;

commencement, enrollment

or results of our clinical trials of our diagnostic tests or any future clinical trials we may conduct;

changes in the development

status of our diagnostic tests;

any delays or adverse developments

or perceived adverse developments with respect to review by the FDA or other similar foreign regulatory authorities of our planned

clinical trials;

any delay in our submission

for studies or test approvals or adverse regulatory decisions, including failure to receive regulatory approval or clearance for

our diagnostic tests;

our announcements or our

competitors’ announcements regarding new tests, enhancements, significant contracts, acquisitions or strategic investments;

failures to meet external

expectations or management guidance;

changes in our capital

structure or dividend policy, including as a result of future issuances of securities and sales of large blocks of common stock by

our shareholders;

announcements and events

surrounding financing efforts, including debt and equity securities;

competition from existing

technologies and diagnostic tests or new technologies and diagnostic tests that may emerge;

announcements of acquisitions,

partnerships, collaborations, joint ventures, new diagnostic tests, capital commitments, or other events by us or our competitors;

changes in general economic,

political and market conditions in any of the regions in which we conduct our business;

changes in industry conditions

or perceptions;

changes in valuations of

similar companies or groups of companies;

analyst research reports,

recommendations and changes in recommendations, price targets and withdrawals of coverage;

departures and additions

of key personnel;

disputes and litigations

related to intellectual properties, proprietary rights, and contractual obligations;

changes in applicable laws,

rules, regulations, or accounting practices and other dynamics;

other events or factors,

many of which may be out of our control.

or purchases of our common stock by our shareholders, executives, and directors;

ability to obtain regulatory approval to commercialize our PCR platform on a timely basis or at all;

ability to enter new markets;

or unanticipated fluctuations in our annual and quarterly financial results;

ability to obtain financings to continue and expand our commercial activities, expand our manufacturing operations, conduct research

and development activities including, but not limited to, human clinical trials, and other business activities;

ability to secure resources and the necessary personnel to continue and expand our commercial activities, develop additional diagnostic

tests, conduct clinical trials and gain approval for our diagnostic tests on our desired schedule;

commencement,

enrollment or results of our clinical trials of our diagnostic tests or any future clinical trials we may conduct;

in the development status of our diagnostic tests;

delays or adverse developments or perceived adverse developments with respect to review by the FDA or other similar foreign regulatory

authorities of our planned clinical trials;

delay in our submission for studies or test approvals or adverse regulatory decisions, including failure to receive regulatory approval

or clearance for our diagnostic tests;

announcements or our competitors’ announcements regarding new tests, enhancements, significant contracts, acquisitions or strategic

to meet external expectations or management guidance;

in our capital structure or dividend policy, including as a result of future issuances of securities and sales of large blocks of

common stock by our shareholders;

announcements

and events surrounding financing efforts, including debt and equity securities;

from existing technologies and diagnostic tests or new technologies and diagnostic tests that may emerge;

announcements

of acquisitions, partnerships, collaborations, joint ventures, new diagnostic tests, capital commitments, or other events by us or

our competitors;

in general economic, political and market conditions in any of the regions in which we conduct our business;

in industry conditions or perceptions;

in valuations of similar companies or groups of companies;

research reports, recommendations and changes in recommendations, price targets and withdrawals of coverage;

and additions of key personnel;

and litigations related to intellectual properties, proprietary rights, and contractual obligations;

in applicable laws, rules, regulations, or accounting practices and other dynamics;

events or factors, many of which may be out of our control.

addition, if the market for stocks in our industry or industries related to our industry, or the stock market in general, experiences

11 unchanged sentences

Among other things, our Amended and Restated Articles of Incorporation and Bylaws:

authorize the issuance

of “blank check” preferred stock that could be issued by our board of directors in response to a takeover attempt;

provide that vacancies

on our board of directors, including newly created directorships, may be filled only by a majority vote of directors then in office,

except a vacancy occurring by reason of the removal of a director without cause shall be filled by vote of the shareholders;

no right to cumulative

limit who may call special

meetings of shareholders;

Provide for a staggered

board of directors

the issuance of “blank check” preferred stock that could be issued by our board of directors in response to a takeover

that vacancies on our board of directors, including newly created directorships, may be filled only by a majority vote of directors

then in office, except a vacancy occurring by reason of the removal of a director without cause shall be filled by vote of the shareholders;

right to cumulative voting;

who may call special meetings of shareholders;

for a staggered board of directors

provisions could have the effect of delaying or preventing a change of control, whether or not it is desired by, or beneficial to, our

12 unchanged sentences

Smaller reporting companies

are able to provide simplified executive compensation disclosures in their filings, and have certain other decreased disclosure obligations in their SEC filings, including,

among other things, only being required to provide two years of audited financial statements in annual reports.

We cannot predict whether

investors will find our common stock less attractive because of our reliance on any of these exemptions.

If some investors find our common

stock less attractive as a result, there may be a less active trading market for our common stock and our stock price may be more volatile.

are able to provide simplified executive compensation disclosures in their filings, and have certain other decreased disclosure obligations

in their SEC filings, including, among other things, only being required to provide two years of audited financial statements in annual

We cannot predict whether investors will find our common stock less attractive because of our reliance on any of these exemptions.

If some investors find our common stock less attractive as a result, there may be a less active trading market for our common stock and

our stock price may be more volatile.

incur substantial costs as a result of being a public company and our management expects to devote substantial time to public company

12 unchanged sentences

stock on The NASDAQ Capital Market, which would likely have a material adverse effect on the trading price of our common stock.

UNRESOLVED STAFF COMMENTS

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 1A. Risk Factors